Quality standard for Dieda analgesic ointment and testing method thereof

A Dieda analgesic ointment, quality standard technology, applied in the field of medicine, can solve the problems of ineffective monitoring of preparations, inability to fully ensure the efficacy of preparations, etc., and achieve high accuracy, good linear relationship, and good repeatability

Inactive Publication Date: 2016-08-24
GUANGZHOU BAIYUNSHAN PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Since the quality standard of the preparation in the Pharmacopoeia is not yet perfect, scientific and reasonable effective monitoring of the preparation cannot be carried out, so that the curative effect of the preparation cannot be fully guaranteed, so it is urgent to improve the quality standard of the preparation

Method used

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  • Quality standard for Dieda analgesic ointment and testing method thereof
  • Quality standard for Dieda analgesic ointment and testing method thereof
  • Quality standard for Dieda analgesic ointment and testing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Implementation method of microscopic identification of embodiment 1 Dieda analgesic ointment

[0045]Take Dieda analgesic ointment, remove the cover lining, cut it into pieces, take a small amount of ointment, and observe it under a microscope: the fiber bundles are bright yellow, and the surrounding cells contain square crystals of calcium oxalate, forming crystal fibers, and the cell walls containing crystals are lignified and thickened ( Treats). Fuchsia fibers and crystal fibers are bundled or scattered individually, the walls are thick, and are evenly wooded (Dalbergia). Bast fiber light yellow, fusiform, thick wall, fine pores and grooves (Scutellaria baicalensis). Calcium oxalate clusters are large, with a diameter of 20-140 μm (rhubarb). Single-celled nonglandular hairs resemble fibers, mostly broken, and the base is enlarged like stone cells, lignified (nychnium). Body wall fragments are yellow or brownish red, with round hairy nests, 8-24 μm in diameter, an...

Embodiment 2

[0046] The implementation method of volatile oil identification in embodiment 2 Dieda analgesic ointment

[0047] Extract according to method A of volatile oil determination method (2015 edition pharmacopoeia general rule 2204 method A), in the liquid in volatile oil measuring device, add ethyl acetate 10ml and shake and extract, divide and get ethyl acetate liquid, as need testing solution; Reference substance, borneol reference substance, methyl salicylate reference substance and camphor reference substance, according to gas chromatography (2015 edition pharmacopoeia general rule 0521) test, draw reference substance solution and need testing solution respectively, inject gas chromatograph, for testing The chromatographic peaks with the same retention time as the chromatographic peaks of the reference substance should appear in the chromatogram of the product.

Embodiment 3

[0048] The qualitative examination method of strychnine in embodiment 3 Dieda analgesic ointment

[0049] Take 5 tablets of Dieda Analgesic Ointment, remove the lid lining, cut into small pieces, put them in a stoppered Erlenmeyer flask, add 60ml of 1mol / L hydrochloric acid solution, soak overnight, ultrasonicate for 20 minutes, filter, and put the filtrate in a separating funnel In the medium, add concentrated ammonia test solution to adjust the pH value to 9-10, shake and extract 3 times with ether (30ml, 20ml, 20ml), combine the ether solution, add anhydrous sodium sulfate to dehydrate, filter, evaporate the filtrate to dryness, and add the residue to Chloroform was dissolved, moved to a 2ml measuring bottle, added chloroform to dilute to the mark, shaken up, and used as the test solution; another appropriate amount of strychnine reference substance was taken, accurately weighed, added chloroform to make each 1ml of the solution containing 6mg is used as the reference subst...

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Abstract

The invention discloses quality standard for Dieda analgesic ointment and a testing method thereof. The quality standard includes an identification item, an inspection item, a volatile oil item and a content determination item; the identification item includes microscopic identification and volatile oil identification; the microscopic identification incudes identification for crystal fiber, bast fiber, calcium oxalate crystal clusters, single cells and cell body walls; the volatile oil identification includes quantitative detection for menthol, borneol, methyl salicylate and camphor; the inspection item includes quantitative inspection for strychnine, quantitative inspection for aconitine, determination for ointment content and provisions with respect to adhesive plasters among 0122 plasters and meeting general rules of Chinese Pharmacopoeia (2015 edition); the volatile oil item includes determination for volatile oil total quantity; the content determination item includes quantitative determination for camphor by gas chromatography. The quality standard established herein and a testing method thereof are high in stability, good linear relation, high in accuracy and good in repeatability, the quality of Dieda analgesic ointment may be evaluated scientifically according to this method, and quality control for industrial production is facilitated.

Description

technical field [0001] The invention relates to the technical field of medicine, and more specifically, relates to a quality standard and a testing method of a traditional Chinese medicine preparation Dieda Analgesic Ointment for treating acute and chronic sprains, chronic lumbago and leg pain, and rheumatism and arthralgia. Background technique [0002] The current standard of Dieda Analgesic Ointment is recorded in the 2015 edition of "Chinese Pharmacopoeia", and the prescription is 48g of ground beetle, 48g of Shengcaowu, 48g of Nuxychia, 48g of rhubarb, 48g of Jiangxiang, 48g of liangmianzhen, 48g of scutellaria baicalensis, Phellodendron Phellodendri 48g, Polygonum cuspidatum 15g, Borneol 24g, Peppermint oil 30g, Camphor 60g, Methyl salicylate 60g, Menthol 30g, the dosage form is ointment, the effect of promoting blood circulation and relieving pain, dispelling stasis and swelling, expelling wind and dampness, used for acute and chronic writhing Contusions, chronic low ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N21/84G01N30/90
CPCG01N30/02G01N21/84G01N30/90G01N2030/025
Inventor 罗双辉陈立嘉梅芬林诗玥朱慧鸿
Owner GUANGZHOU BAIYUNSHAN PHARM CO LTD
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